xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test
Check against the official notice below — it lists the full affected range.
Luminex Molecular Diagnostics is recalling the xTAG Respiratory Viral Panel (RVP) test kit with catalogue number I019C0111 because the test may produce false negative results when detecting and subtyping Influenza A (H3) and detecting RSV A in patient samples. The test will still correctly detect Influenza A, Influenza B, RSV B, and all other respiratory virus targets it is designed to identify. A total of 56 kits were distributed to laboratories in California, Connecticut, Massachusetts, and Pennsylvania.
The affected kits have lot numbers IK019C-0129, IK019C-0130, IK019C-0131, and IK019C-0132. The source document does not specify a remedy or recommended action for consumers or healthcare providers who may have received or used these kits.
Written by software from the official notice below. Not reviewed by a lawyer.
The Assay may give a false negative result when detecting and subtyping Influenza A (H3) and detecting RSV A in patient specimens. However, the assay will continue to detect Influenza A, Influenza B, RSV B and all other targets in accordance with each of these products performance claims.
Reason for recall: The Assay may give a false negative result when detecting and subtyping Influenza A (H3) and detecting RSV A in patient specimens. However, the assay will continue to detect Influenza A, Influenza B, RSV B and all other targets in accordance with each of these products performance claims. Distribution: US distribution to CA, CT, MA, and PA OUS: None Quantity: 56 Kits Lot/code info: Catalogue Number:I019C0111 Device UDI: 00840487100462 Lot Numbers: IK019C-0129 IK019C-0130 IK019C-0131 IK019C-0132
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.